EPZM
EpizymeNASDAQ
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  • Mon, Nov. 28, 11:11 AM
    • The FDA designates Epizyme's (EPZM -1.7%) lead product candidate tazemetostat for Fast Track review for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with an EZH2-activating mutation.
    • In addition, the company announces that it has expanded the epithelial sarcoma cohort to 60 subjects (from 30) in its ongoing Phase 2 study in patients with genetically defined solid tumors after observing encouraging activity.
    • On the negative front, development in synovial sarcoma has been terminated due to the lack of sufficient effect.
    • Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers. It is being developed for the treatment of non-Hodgkin lymphoma, certain genetically defined solid tumors and (until now) synovial sarcoma.
    | Mon, Nov. 28, 11:11 AM | 1 Comment
  • Thu, Nov. 3, 6:35 AM
    • Epizyme (NASDAQ:EPZM): Q3 EPS of -$0.42 beats by $0.18.
    • Revenue of $6.58M (+1727.8% Y/Y) beats by $6.11M.
    • Press Release
    | Thu, Nov. 3, 6:35 AM
  • Thu, Sep. 15, 7:19 AM
    • Epizyme (NASDAQ:EPZM) earns a $6M milestone payment from licensee GlaxoSmithKline (NYSE:GSK) on the basis of Glaxo's initiation of a Phase 1 clinical trial evaluating cancer therapy candidate GSK3326595 (formerly EPZ015938).
    • GSK3326595 inhibits an enzyme called protein arginine methyltransferase-5 (PRMT5), a protein methyltransferase that plays a role in the formation of tumors. The Phase 1 is a dose-escalation study to assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3326595 in patients with solid tumors and non-Hodgkin lymphoma.
    • Under its collaboration and license agreement with Epizyme, GSK has exclusive global rights to methyltransferase inhibitors directed to three targets. GSK3326595 is the first one to enter the clinic.
    | Thu, Sep. 15, 7:19 AM
  • Mon, Aug. 8, 12:50 PM
    | Mon, Aug. 8, 12:50 PM | 3 Comments
  • Mon, Aug. 8, 11:01 AM
    | Mon, Aug. 8, 11:01 AM
  • Mon, Aug. 8, 7:48 AM
    • Epizyme (EPZM) Q2 results: Revenues: $0.5M (-28.6%); R&D Expense: $21.5M (+4.4%); SG&A: $7.4M (+23.3%); Operating Loss: ($28.4M) (-10.1%); Net Loss: ($28M) (-8.5%); Loss Per Share: ($0.49) (+22.2%); Quick Assets: $89.5M (-57.0%).
    | Mon, Aug. 8, 7:48 AM
  • Mon, Aug. 8, 6:34 AM
    • Epizyme (NASDAQ:EPZM): Q2 EPS of -$0.49 beats by $0.03.
    • Revenue of $0.47M (-36.5% Y/Y) misses by $0.41M.
    • Press Release
    | Mon, Aug. 8, 6:34 AM
  • Wed, Jun. 22, 12:36 PM
    • Epizyme (EPZM +0.6%) and Roche's (OTCQX:RHHBY) Genentech will collaborate on a Phase 1b clinical trial to evaluate the combination of tazemetostat and Tecentriq (atezolizumab) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the agreement, the companies will supply their respective products and equally share the costs of the study. Genentech will manage the trial. Enrollment should commence later this year.
    • Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers.
    • Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor. The FDA approved it for the treatment of a type of bladder cancer called urothelial carcinoma in May.
    | Wed, Jun. 22, 12:36 PM
  • Mon, Jun. 20, 11:40 AM
    • Preliminary results from a Phase 2 clinical trial assessing Epizyme's (EPZM -3.7%) lead product candidate, orally administered tazemetostat, in heavily pre-treated patients with certain types of diffuse large B-cell lymphoma (DLBCL) showed a disease control rate as high as 60%. In addition, all the lymphoma cohorts have passed futility analyses by the Independent Data Monitoring Committee. The data were presented at the American Society of Hematology Meeting on Lymphoma Biology.
    • There were 47 efficacy-evaluable patients in four cohorts: three DLBCL (n=44) and one follicular lymphoma (FL) with EZH2 mutations (n=3). The three DLBCL group were further divided into those with the subtype GCB (Germinal Center B-cell) and EZH2 mutations (n=5), those with GCB and wild-type EZH2 (n=19) and those with non-GCB subtype (n=20).
    • The disease control rates (DCRs) for the three DLBCL cohorts were 60% (n=3/5), 47% (n=9/19) and 55% (n=11/20), respectively. The DCR for the FL cohort was 100% (n=3/3), but the futility assessment has not been reached. Patient enrollment is continuing.
    • DCR includes complete responders, partial responders and those with stable (non-progressive) disease.
    • Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers. It is being developed for the treatment of non-Hodgkin lymphoma, certain genetically defined solid tumors and synovial sarcoma.
    | Mon, Jun. 20, 11:40 AM
  • Mon, May 9, 10:24 AM
    • Epizyme (EPZM +2.6%) enters into a collaboration agreement with the Lymphoma Study Association (LYSA), a leading cooperative group in France dedicated to research in lymphoma, to investigate the combination of lead product candidate tazemetostat with R-CHOP chemo as front-line treatment of diffuse large B-cell lymphoma.
    • Under the agreement, the Lymphoma Academic Research Organization, the operational arm of LYSA, and the company will jointly conduct an open-label Phase 1b/2 study across multiple sites in France.
    • Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers. It is being developed for the treatment of non-Hodgkin lymphoma, certain genetically defined solid tumors and synovial sarcoma.
    | Mon, May 9, 10:24 AM
  • Mon, May 9, 6:42 AM
    • Epizyme (NASDAQ:EPZM): Q1 EPS of -$0.41 beats by $0.12.
    • Revenue of $0.47M (-48.4% Y/Y) misses by $0.43M.
    | Mon, May 9, 6:42 AM
  • Fri, Mar. 18, 12:56 PM
    • Vitae Pharmaceuticals (VTAE +8.2%) upgraded to Buy from Hold by Stifel. Price target set at $15 (105% upside).
    • Johnson & Johnson (JNJ +0.8%) upgraded to Overweight from Neutral by JP Morgan. Price target raised to $112 (4% upside) from $102.
    • HCA Holdings (HCA +2.8%) upgraded to Overweight from Neutral by JP Morgan. Price target raised to $85 (12% upside) from $76.
    • Epizyme (EPZM +9.8%) upgraded to Buy from Neutral by H.C. Wainwright. Price target raised to $25 (127% upside) from $22.
    • Agenus (AGEN +2.7%) upgraded to Buy from Hold with a $7 (81% upside) price target by Maxim Group.
    • Juno Therapeutics (JUNO +2.6%) upgraded to 4.5 stars (out of a possible 5.0) by the Vetr Community. The implied price target is $45.47 (17% upside).
    • Alnylam Pharmaceuticals (ALNY +3.2%) upgraded to Overweight from Neutral by JP Morgan. Price target lowered to $81 (37% upside) from $111.
    • Amicus Therapeutics (FOLD +4.3%) upgraded to Buy from Neutral by Janney Capital. Price target raised to $12 (59% upside) from $10.
    • Pernix Therapeutics Holdings (PTX -5%) downgraded to Market Perform from Outperform by Oppenheimer. $9 price target removed.
    • Valeant Pharmaceuticals (VRX -6.6%) downgraded to Neutral from Buy by Nomura. Price target lowered to $60 (116% upside) from $175. Morgan Stanley maintains Equal Weight rating but lowers price target to $39 (40% upside) from $98. Stifel rates it a Buy but lowered its price target to $65 (134% upside) from $200. Rodman & Renshaw rates it a Buy with a $118 (324% upside) price target (from $150). Piper Jaffray downgraded it to Underweight from Neutral with no price target.
    • AstraZeneca (AZN -1.5%) downgraded to Hold from Buy by Jefferies. Price target lowered to 4,350p (12% upside) from 4,900p.
    • Cardinal Health (CAH +1.4%) and McKesson (MCK +4.4%) both downgraded to Market Perform from Outperform by Cowen & Company. Price targets lowered to $90 (11% upside) and $173 (9% upside), respectively.
    | Fri, Mar. 18, 12:56 PM | 27 Comments
  • Wed, Mar. 9, 7:25 AM
    • Epizyme (NASDAQ:EPZM) says its corporate strategy through 2020 will focus on four transformative activities:
    • Transitioning to a commercial stage company via its global launch of tazemetostat for non-Hodgkin lymphoma (NHL) and certain other genetically defined solid tumors.
    • Expanding the clinical development of tazemetostat to support its use in earlier lines of therapy, in combination regimens, and in at least five new tumor types.
    • Growing its pipeline with at least three new cancer candidates in clinical development and a robust lineup of preclinical assets.
    • Building the firm's leadership position in epigenetics and chromatin remodeling in oncology and beyond with the aim of driving long-term growth.
    • Tazemetostat inhibits an enzyme called EZH2 (enhancer of zeste homolog 2), which plays a key role in DNA methylation and transcriptional repression. Mutation or over-expression of EZH2 is associated with a range of cancers. It is currently being evaluated in two Phase 2 studies (NHL and genetically defined solid tumors) and a Phase 1 trial in pediatric patients with genetically defined tumors.
    • According to clinicaltrials.gov, the estimated completion date of the Phase 2 study in genetically defined tumors is January 2018. The estimated completion date of the Phase 1 pediatric study is also January 2018.
    | Wed, Mar. 9, 7:25 AM
  • Wed, Mar. 9, 7:06 AM
    • Epizyme (EPZM) Q4 results: Revenues: $0.6M (-94.2%); R&D Expense: $16.8M (-18.0%); SG&A: $6M (+22.4%); Operating Loss: ($22.3M) (-47.7%); Net Loss: ($22.2M) (-48.0%); Loss Per Share: ($0.53) (-20.5%).
    • FY2015 results: Revenues: $2.6M (-93.7%); R&D Expense: $111.2M (+47.1%); SG&A: $23.9M (+14.4%); Operating Loss: ($132.5M) (-140.5%); Net Loss: ($132.4M) (-140.7%); Loss Per Share: ($3.32) (-98.8%); Quick Assets: $208.3M (+9.6%).
    • No guidance given.
    | Wed, Mar. 9, 7:06 AM
  • Wed, Mar. 9, 6:32 AM
    • Epizyme (NASDAQ:EPZM): Q4 EPS of -$0.53 beats by $0.12.
    • Revenue of $0.56M (-94.6% Y/Y) misses by $0.01M.
    | Wed, Mar. 9, 6:32 AM
  • Mon, Feb. 8, 8:40 AM
    • The FDA designates Epizyme's (NASDAQ:EPZM) tazemetostat an Orphan Drug for the treatment of malignant rhabdoid tumors, a rare soft tissue cancer predominately strikes infants and toddlers but occurs in adults as well.
    • A Phase 1 dose escalation and safety study in soft tissue cancer commenced in December. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is October 2017. The estimated study completion date is January 2018. Interim data are expected in Q4.
    • Tazemetostat is a small molecule inhibitor of EZH2, an enzyme that is upregulated in certain cancers.
    • Among the benefits of Orphan Drug status is a seven-year period of market exclusivity for the indication, if approved.
    | Mon, Feb. 8, 8:40 AM | 1 Comment